Communication Bridge: A person-centered Internet-based intervention for individuals with primary progressive aphasia

项目摘要/摘要 语言和交流障碍(失语症)是临床神经退行性疾病的主要特征 痴呆综合征原发性进行性失语(PPA)，可由阿尔茨海默病(AD)或 额颞叶变性。通信的破坏对生活质量产生了负面影响 与PPA生活在一起的人和他们的护理伙伴。PPA中的沟通困难也会缩小生活空间 机动性，减少社交互动，降低社区活动参与度。非药理作用 包括言语-语言和心理社会干预在内的干预措施可能会对 PPA患者及其护理伙伴的生活质量，但历史上也缺乏疗效证据 作为指导最佳临床护理实践的指南。我们一直在改变这种情况，通过 通信桥(CB)干预的开发具有战略性的阶段性严格临床试验 正走在实施的道路上。CB1试验确定了在一年内提供我们的干预的可行性 通过远程实践实现全球规模，并在功能性通信成果方面取得了显著进展 在基线后维持6个月。接下来，CB2试验提供了第一个严格的2a阶段，第二阶段，优势， PPA患者言语-语言干预的随机对照试验。本项目提出了CB3 试验，阶段2b，阶段II，随机对照试验，以测试言语-语言干预与 心理社会教育和咨询干预(实验)在以下方面表现出更好的反应 与单纯CB干预相比，PPA患者及其护理伙伴的主要结果 (控制)。目标1a将作为区域协调机制的补充，目标1a将审查干预机制；目标1a 1B，将在务实试验准备情况评估(RAPT)之后评估务实试验准备情况 模型；以及目标2，将使用新型可穿戴传感器来探索功能结果，以客观测量 使用‘生活-空间’移动框架的生活参与。试验结果将决定采取哪种干预措施 期待实施。由于交付模式和主要结果，翻译潜力很高 与当前的临床实践相一致。在缺乏治疗阿尔茨海默病和相关的神经退行性变的确切方法的情况下 对于疾病，重要的是确定和评估帮助个人最大限度提高生活质量的战略，以及 这个项目将有助于满足这一需求。

PROJECT SUMMARY/ABSTRACT Language and communication impairments (aphasia) are the defining features of the clinical neurodegenerative dementia syndrome primary progressive aphasia (PPA), which can be caused by Alzheimer’s disease (AD) or frontotemporal lobar degeneration. The devastation of communication negatively impacts quality of life for persons living with PPA and their care partners. Communication difficulties in PPA can also reduce life-space mobility, shrink social interactions, and lower participation in community activities. Nonpharmacological interventions, including speech-language and psychosocial intervention, may offer significant benefit to the quality of life for persons with PPA and their care partners, but have historically lacked efficacy evidence as well as guidelines to direct best clinical care practices. We have been changing this landscape, through the development of the Communication Bridge (CB) intervention with strategically staged, rigorous clinical trials that are on a path towards implementation. The CB1 trial established feasibility of delivering our intervention at a global scale via telepractice and demonstrated gains in functional communication outcomes that were maintained 6-months post baseline. Next, the CB2 trial provided the first rigorous Phase 2a, Stage II, superiority, randomized controlled trial (RCT) of speech-language intervention in PPA. This project proposes the CB3 trial, a Phase 2b, Stage II, RCT to test whether the combined speech-language intervention with psychosocial education and counselling intervention (Experimental) shows superior response in primary outcomes for persons with PPA and their care partners compared to the CB intervention alone (Control). The RCT will be complemented by Aim 1a, which will examine mechanisms of the interventions; Aim 1b, which will assess pragmatic trial readiness following the Readiness Assessment for Pragmatic Trials (RAPT) model; and Aim 2, which will explore functional outcomes with novel wearable sensors to objectively measure life participation using a ‘Life-Space’ mobility framework. Trial outcomes will determine which intervention to put forward for implementation. The translational potential is high since the delivery model and primary outcomes are aligned with current clinical practice. In the absence of a definitive cure for AD and related neurodegenerative diseases, it is important to identify and evaluate strategies that help individuals maximize their quality of life, and this project will help fulfill this need.